The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.

Device Description

The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.

The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.

AI/ML Overview

The provided document describes the 510(k) summary for the Arc Surgicals Manufacturing LLC's V-Guide for Ventriculostomies (K141559), a neurological stereotaxic instrument designed for frontal placement of an intraventricular catheter. The document seeks to establish substantial equivalence to a legally marketed predicate device, the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide (K854475).

Here's an analysis of the acceptance criteria and the study that proves the device meets the criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (V-Guide)	Reported Device Performance (V-Guide)
Accuracy at 90° (Sagittal angle 0, Lateral Angle 0)	Accurate to ± 3.0mm with a target depth of 6 cm.
Comparison to Predicate Device (Ghajar Guide)
Same technological characteristics	The V-Guide has "the same technological characteristics" as the Ghajar Guide in terms of guiding catheters for ventriculostomies, having 3 legs to position over the burr hole, placing catheters at 90° (perpendicular) to the skull (when set to 0 degrees), visual placement over the burr hole, hand-held during insertion, and being made of plastic material.
	Differences: The V-Guide allows objective changes in catheter angle, while the Ghajar Guide is only indicated for 90-degree placement. The V-Guide is compatible with 3.3mm catheters, while the Ghajar Guide is 1.30-3.25mm. The V-Guide uses ABS with Stainless Steel Legs, while the Ghajar Guide uses plastic. Sterilization methods differ.
Biocompatibility of Stainless Steel Legs	Established based on the use of a Covidien product (Monoject™ Standard Hypodermic Needle, Aluminum Hub, 16 G x 1") cleared under 510(k) K854547.
Performance comparable to predicate for safety and function	The non-clinical performance data "supports the safety of the device and the hardware verification demonstrate that the V-Guide device should perform as intended in the specified use conditions." The data demonstrate that the "V-Guide device performs comparably to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "a bench model" for accuracy testing, but does not provide details on the number of trials, measurements, or the total sample size used in this testing.
Data Provenance: The study was a non-clinical bench test. There is no information regarding country of origin, retrospective, or prospective nature, as it was not a clinical study on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. The "ground truth" for the accuracy test was established by the physical setup of the bench model with a target at a known depth (6 cm) and the objective measurement of the V-Guide's placement accuracy. This is a technical measurement, not an expert-driven assessment.
Qualifications of Experts: Not applicable for establishing ground truth in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. The testing described is a technical performance assessment against a defined physical target, not an assessment requiring adjudication of human interpretations or classifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical stereotaxic instrument, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable in the context of an algorithm. This device is a physical instrument intended for use by a surgeon (human-in-the-loop) during a medical procedure. The "standalone" performance here refers to the instrument's accuracy as measured on a bench model, independent of a human surgeon's skill in operating it, other than to set it up for the test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth for the accuracy testing was physical measurement against a known target. Specifically, the accuracy was measured in relation to a target at a 6 cm depth within the "bench model." The predicate device's performance was also tested against this same physical ground truth for comparison.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This document describes the testing of a medical device's physical performance, not the training of an AI algorithm.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three bars above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

Arc Surgicals Manufacturing LLC. Craig Pagan Consultant 1135 W Nasa Blvd Ste 500 Melbourne, Florida 32901

Re: K141559

Trade/Device Name: V-guide for Ventriculostomies Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 10, 2014 Received: June 12, 2014

Dear Craig Pagan,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141559

Device Name V-Guide for Ventriculostomies

Indications for Use (Describe)

The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter's name, address, telephone number, a contact person and date (1) summary was prepared:

ARC Surgicals Manufacturing LLC 3259 Progress Drive Suite 166 Orlando, FL 32826 Tel: 407-203-9590 Contact: Habeel Gazi, Director Email: habeel@arcsurgicals.com June 9, 2014 Date Prepared:

Name(s) of device: (2)

Proprietary/Trade Name:	V-Guide for Ventriculostomies
Common Name:	Neurological stereotaxic instrument
Classification Name:	Stereotaxic Instrument
Classification Panel:	Neurology
Product Code:	HAW
Regulatory Class:	II
Regulation Number	21 CFR 882.4560

Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:

Arc Surgical Manufacturing's V-Guide for Ventriculostomies is substantially equivalent to the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide – K854475.

(4) Description of device(s):

V-Guide for Ventriculostomies (Reorder # 7000)

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as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.

Indications for Use: (5)

The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.

Comparison of Technological Characteristics to Predicate Device: (6)

The V-Guide for Ventriculostomies has the same technological characteristics as the predicate device, the Ghajar Guide (K854475) as described below:

devices are designed to guide catheters for Ventriculostomies ●
devices have 3 legs that position the device over the burr hole ●
devices are designed to place catheters at 90° (perpendicular) to the skull ●
devices are visually placed over the burr hole
devices are hand held during insertion of the catheter
both devices are made of plastic material ●

Differences:

The main difference between the V-Guide and the predicate Ghajar Guide is that the V-Guide allows the user to make objective changes in the direction of the catheters angle to the cranium.

ProductInformation	V-GuideThis submission	Ghajar IntraventricularCatheter Guide	Similarities andDifferences
FDA Classification	Class II	Class II	Same
Regulation Number	21 CFR 882.4560	21 CFR 882.4560	Same
Product Code	HAW	HAW	Same
Indications for Use	The V-Guide is designedto be used for frontalplacement of anintraventricular catheterduring a ventriculostomy.The device is for use withintraventricular catheters.	The Ghajar Guide isdesigned to be used as adevice for anteriorplacement of anintraventricular catheter atninety degrees to the skullsurface.	Both devices areindicated for frontal oranterior placement ofintraventricularcatheters.The Ghajar Guide is onlyindicated for placementat 90 degrees to the skull

Substantial Equivalence Comparison

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ProductInformation	V-GuideThis submission	Ghajar IntraventricularCatheter Guide	Similarities andDifferences
			surface, whereas the VGuide allows thephysician make objectivechanges in the directionof the catheters angle tothe skull.
CatheterCompatibility	3.3mm	1.30 - 3.25mm	V-Guide is compatiblewith one size catheter -3.3mm OD whereas theGhajar Guide iscompatible with catheterfrom 1.30 – 3.25mmOD.
Materials	ABS with Stainless SteelLegs (See note 1)	Plastic	The bodies of bothdevices are the same -plastic. The Legs of theV Guide are made ofstainless steel rather thanplastic. Comparativetesting showscomparableperformance.
Accuracy	$\pm$ 3mm at 6cm targetdepth	Unknown	Same – based on benchtest data the V Guidewas comparable to theGhajar guide.
SterilizationMethod	Gamma	Ethylene Oxide	Sterilization process isdifferent, but SAL 10-6 isthe same.
Single Use	Yes	Yes	Same
Packaging	PETG Tray with Tyveklid	PETG Tray with Tyvek lid	Same

Biocompatibility of the Stainless Steel Legs was established based on the Note 1: Covidien product # 8881200052 Monoject™ Standard Hypodermic Needle, Aluminum Hub, 16 G x 1" (1.651 mm x 2.5 cm) A. The FDA classifies this product is a class II device, which is cleared under 510k K854547.

(7) Performance Data:

The following nonclinical testing was performed in order to evaluate the substantial equivalence of the V-Guide to the predicate device:

Accuracy Testing at 90° at 90° (Sagittal angle adjustment set at 0 and ● Lateral Angle (Barrel) set at 0) the V-Guide will be accurate to ± 3.0mm with a target depth of 6 cm.

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This test verified the accuracy of the device using a bench model with a target at 6 cm depth. The accuracy of the V-Guide was compared to the predicate device (Ghajar Guide) using the same bench model. The results of the tests shows that the V-Guide is comparable to the accuracy of the predicate device.

Conclusions: (8)

Based on the non-clinical performance data performed comparing the Arc Surgicals Manufacturing V-Guide to the predicate device, it is concluded that the data supports the safety of the device and the hardware verification demonstrate that the V-Guide device should perform as intended in the specified use conditions. The data demonstrate that the V-Guide device performs comparably to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).